SpringWorks: CHMP Adopts Positive Opinion For Mirdametinib

(RTTNews) - SpringWorks Therapeutics (SWTX) announced that the European Medicines Agencys Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of a conditional marketing authorization for mirdametinib, a MEK inhibitor, for the treatment of symptomatic, inoperable plexiform neurofibromas in pediatric and adult patients with neurofibromatosis type 1 aged 2 years and above. The European Commission will review the CHMP opinion and is expected to make a final decision regarding the approval in the third quarter of 2025.

The CHMP opinion was based on the Marketing Authorization Application for mirdametinib, which was validated by the EMA in August 2024.

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